Drug product
Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals, Inc., The Physicians Solutions.
D-1390-2020
Product summary
- Event
- Event 86002
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1390-2020
Official wording
Reason: CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Code information: Lot Numbers: H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, G0519G; Exp: 5/31/2021.
Distribution pattern: Nationwide within the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations